TALENTACE Trial Reveals Efficacy of TACE Plus Atezolizumab in HCC

In a significant advancement for the treatment of unresectable hepatocellular carcinoma (HCC), data from the TALENTACE trial demonstrate that the combination of transarterial chemoembolization (TACE) with atezolizumab (Tecentriq) and bevacizumab (Avastin) significantly improves progression-free survival (PFS) in patients with intermediate-to-high tumor burden HCC. The findings, presented at the 2025 ESMO Gastrointestinal Cancers Congress in Barcelona, indicate that this regimen could represent a new standard in the management of this challenging cancer type.

The TALENTACE trial (NCT04712643) is noted for being the first phase 3 study to evaluate the efficacy and safety of on-demand TACE combined with both atezolizumab and bevacizumab in a population of patients who had not previously received systemic therapy. Dr. Guohong Han, a principal investigator from the Department of Gastroenterology at Xi’an International Medical Center Hospital in China, stated, "TALENTACE is pioneering in demonstrating a new and effective treatment option for patients with systemically untreated, unresectable HCC."

According to the trial data, 342 patients were randomly assigned to either the combination therapy group or a control group receiving TACE alone. The median TACE-PFS for the combination group was reported at 11.30 months (95% CI, 7.52-15.01), compared to 7.03 months (95% CI, 5.32-8.41) for those receiving TACE alone, thereby meeting the primary endpoint with a hazard ratio (HR) of 0.71 (P = 0.009). Additionally, the 12- and 24-month TACE-PFS rates were significantly higher in the combination arm at 48.46% and 37.98%, versus 33.60% and 29.85% in the control group.

In terms of safety, the combination therapy was found to have a manageable profile consistent with the known effects of the individual drugs. All patients in the combination arm experienced at least one adverse event (AE), while 99.4% in the TACE-only group reported AEs. Serious AEs occurred in 40.4% of the combination arm compared to 23.7% in the control arm, with the most common treatment-related AEs including proteinuria, hypertension, and post-embolization syndrome.

Dr. Han emphasized that no new safety signals were identified, and the adverse effects were generally manageable, which is critical for the ongoing treatment of patients with HCC, a cancer often characterized by limited therapeutic options.

The study's primary endpoints also included overall survival (OS), although this data was deemed immature at the time of the analysis. The median OS was recorded at 34.53 months for the combination therapy and 35.38 months for TACE alone, indicating that while the combination may enhance PFS, its impact on overall survival requires further investigation.

The trial enrolled participants with confirmed unresectable HCC, requiring specific eligibility criteria including Child-Pugh A disease and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were stratified by baseline characteristics such as alpha-fetoprotein levels and prior locoregional therapy.

This research is particularly timely as HCC continues to be a leading cause of cancer-related mortality worldwide, predominantly affecting individuals with underlying liver disease. According to the World Health Organization, liver cancer incidence is on the rise, underscoring the urgent need for effective treatment strategies.

In summary, the TALENTACE trial results suggest that combining TACE with atezolizumab and bevacizumab could provide significant clinical benefits for patients with unresectable HCC. As the medical community anticipates further results regarding overall survival, the findings present a hopeful advancement in therapeutic options for a patient population in dire need of effective treatments. The study was sponsored by Shanghai Roche Pharmaceuticals Ltd, with various disclosures from Dr. Han regarding funding and consulting roles with pharmaceutical companies involved in the study.